Cambio - Excellence in Molecular Biology

<b>New </b> - Biopharma Quality Control

New - Biopharma Quality Control : Vector Copy Number Determination

Vector Copy Number Determination

 

Determination of vector copy number (VCN) by digital PCR with MiQuant® CAR-T Cell Lenti – dPCR.

  • In-Process Control and Release Testing
  • Compatible with different dPCR/ddPCR platforms
  • Quantitation of VCN without standard curve
  • Works with human or other mammalian cells
  • Accurate and reproducible results
  • Calculation of VCN with analysis software
  • Lyophilized kit components simplify logistics and storage

The determination of vector copy number (VCN) in cell therapies is a critical step in assessing the potency and consistency of these advanced medicinal products. VCN refers to the average copies of integrated lentiviral vectors per cell genome after ex vivo transduction. To minimize the risk of insertional mutagenesis, the FDA recommends a VCN < 5.

The MiQuant® CAR-T Cell kits have been developed for the determination of VCN in transduced cells. After extracting genomic DNA, the copies of the lentiviral gene are determined in relation to the human housekeeping gene PCBP2 by digital PCR.

This kit provides a specific primer/probe mix and offers an open-platform solution for use with various dPCR devices (QIAcuity®, ddPCR™, Quantstudio™ Absolute Q™). The use of digital PCR enables absolute quantitation of VCN without a standard curve.

Application Areas

The MiQuant® CAR-T Cell kits can be used for VCN determination during the production process as an in-process control and prior to infusion into the patient as final QC release testing. Besides these applications the MiQuant® CAR-T Cell kits can also be used for determining VCN in cell culture samples in research and development.

Calculate the Vector Copy Number with our tool.
Data Analysis Application

MiQuant® CAR-T Cell Lenti – dPCR

The MiQuant® CAR-T Cell Lenti – dPCR kit is intended for the determination of vector copy numbers (VCN) in transduced cells to determine the average copies of integrated lentiviral vectors per cell genome after ex vivo transduction via digital PCR (dPCR).

Minerva Biolabs

Catalogue No.DescriptionPack SizePriceQty
  • Change to:
  • £
58-0701MiQuant® CAR-T Cell Lenti – dPCR35ul primer/probe mix €502.68 Quantity Add to Order
58-0702MiQuant® CAR-T Cell Lenti – dPCR140ul primer/probe mix POA Quantity Add to Order

Description

This kit provides a specific primer/probe mix and offers an open-platform solution for use with various dPCR devices (QIAcuity®, ddPCR™, Quantstudio™ Absolute Q™). MiQuant® CAR-T Cell Lenti – dPCR works for all HIV-1 based lentivirus transduction systems.

Type of PCR

Digital PCR (dPCR)

Kit Components
  • MiQuant® Lenti Mix (lyophilized)
  • Positive Control DNA (lyophilized)
  • dPCR grade Water
Package Size

Cat. No. 58-0701: 35 µl primer/probe mix

Cat. No. 58-0702: 140 µl primer/probe mix

Since every dPCR device requires different PCR reaction volumes, the number of PCR reactions are shown in the following table.

Number of PCR reactions

Result Evaluation

Absolute Quantification

Required Lab Device and Consumables
  • Digital PCR device with corresponding consumables (plates or stripes)
    • QIAcuity®
    • Quantstudio™ Absolute Q™
    • QX600™ or QX200™ ddPCR™
  • Corresponding Mastermix (QIAcuity® Probe PCR Kit (4x), Absolute Q™ DNA Digital PCR Master Mix (5x), ddPCR™ Multiplex Supermix (4x) or ddPCR™ Supermix for Probes (2x))
  • MiQuant® SP Beads (sample preparation kit, Cat. No. 56-4010/-4100)
  • 1.5 ml reaction tubes (low-bind, DNA- and RNA-free)
  • Microcentrifuge for 1.5 ml PCR tubes
  • Vortex mixer
  • Pipettes with corresponding filter tips

Optional:

  • Restriction enzymes (EcoRI-HF and NruI-HF; 20 U/μl)
  • PCR Clean™ (Cat. No. 15-2025 and 15-2001)
Shelf Life and Storage

Shipment at ambient temperature. The expiry date of the unopened package is marked on the package label. The kit components must be stored at 2 to 8°C until use. The rehydrated components must be stored at ≤ -18°C for a maximum of one month.

If you cannot find the answer to your problem then please contact us or telephone +44 (0)1954 210 200

Applications & Benefits

Recommended Use

 

MiQuant® CAR-T Cell Lenti – dPCR can be used for the characterization of cellular products and for in-process control as well as final QC release testing in cell therapy production processes. Besides these applications the MiQuant® CAR-T Cell Lenti – dPCR kit can also be used for determining VCN in cell culture samples in research and development and is applicable for human or other mammalian cells (such as mice and rats).

If you cannot find the answer to your problem then please contact us or telephone +44 (0)1954 210 200